The following data is part of a premarket notification filed by Infusion Safety Products, Inc. with the FDA for Isp Safety Huber Needle Infusion Set.
| Device ID | K170881 |
| 510k Number | K170881 |
| Device Name: | ISP Safety Huber Needle Infusion Set |
| Classification | Non-coring (huber) Needle |
| Applicant | Infusion Safety Products, Inc. 26 Victoria Court Keene, NH 03431 |
| Contact | Alan P. Reid |
| Correspondent | Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Rd., Bldg. 1, Suite 300 Austin, TX 78746 |
| Product Code | PTI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-24 |
| Decision Date | 2017-12-14 |
| Summary: | summary |